ArticleTrials2023
Challenges regarding informed consent in recruitment to clinical research: a qualitative study of clinical research nurses' experiences.
Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 22 citations in OpenAlex.
- Patient-Centered Activities Performed by Clinical Research Nurses in Clinical Trials: A Scoping Review of Enacted Practice.Healthcare (Basel, Switzerland) · 2026Review
- Ethical Challenges in Research Involving Hospitalized Patients: A Phenomenological Study.Health care analysis : HCA : journal of health philosophy and policy · 2026Article
- Nursing-Led Support Across the Standard Care-Clinical Trial-Standard Care Pathway in Inflammatory Bowel Disease: A Review With Realist-Informed Interpretation.JGH open : an open access journal of gastroenterology and hepatology · 2026Review
- Drivers of Research Participation Among Racially and Ethnically Underrepresented Women: Insights from Semi-Structured Interviews.Journal of racial and ethnic health disparities · 2026Article
- Scoping review of oncology clinical trials nursing: Roles, competencies, and evolving practice in cancer research.Canadian oncology nursing journal = Revue canadienne de nursing oncologique · 2026Article
- Article
- Legal and ethical conflicts in hospital settings: thematic synthesis of qualitative studies focused on nursing practice.BMC medical ethics · 2025Article
- An ideal portrait of the professional competence of clinical research nurses: A qualitative study.Asia-Pacific journal of oncology nursing · 2025Article
- Article
- Article
- Patient-Centred Communication as a Mediator of Nurses' Safety-Care Activities.Scandinavian journal of caring sciences · 2025Article
- Finding trials for participants: an ethnographic study of successful recruitment strategies for clinical trials.Trials · 2025Article
- Uncovering the Professional Landscape of Clinical Research Nursing: A Scoping Review with Data Mining Approach.Nursing reports (Pavia, Italy) · 2025Review
- Informed consent: Navigating the bioethical complexities of clinical research.Bioinformation · 2025Article
- The status quo and influencing factors of clinical research nurses' participation in preoperative blood sampling in patients with pulmonary nodules.Journal of research in nursing : JRN · 2024Article
- Navigating the challenges of clinical trial professionals in the healthcare sector.Frontiers in medicine · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundClinical research nurses (CRNs) have first-hand experience with ethical challenges and play a crucial role in upholding ethical conduct and adherence to the principles of informed consent in clinical research. This study explores the ethical challenges encountered by CRNs in the process of obtaining informed consent for clinical research.
methodsA qualitative exploratory design. Semistructured interviews (n = 14) were conducted with diverse CRNs in Sweden. These CRNs covered a wide range of research fields, including pharmaceutical and academic studies, interventions, and observational research, spanning different trial phases, patient categories, and medical conditions. The interviews were analysed using inductive qualitative content analysis.
resultsThe analysis identified three main categories: (i) threats to voluntariness, (ii) measures to safeguard voluntariness, and (iii) questionable exclusion of certain groups. CRNs face challenges due to time constraints, rushed decisions, information overload, and excessive reliance on physicians' recommendations. Overestimating therapeutic benefits in stages of advanced illness emerged as a risk to voluntariness. CRNs outlined proactive solutions, such as allowing ample decision-making time and offering support, especially for terminally ill patients. Concerns were also voiced about excluding certain demographics, such as those with language barriers or cognitive impairments.
conclusionsIn conclusion, upholding ethical research standards requires recognising various factors affecting patient voluntariness. Researchers and CRNs should prioritise refining the informed consent process, overcoming participation challenges, and aligning scientific rigour with personalised care. Additionally, a concerted effort is vital to meet the diverse needs of patient populations, including equitable inclusion of individuals with language barriers or cognitive limitations in clinical studies. These findings have significant implications for enhancing the ethics of clinical research and advancing person-centred care.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.